NCT00661011终止2 期
A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 22
- 主要终点
- Survival
研究概览
简要总结
The purpose of this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of non-small cell carcinoma of the lung
- •Initially stage III NSCLC
- •Pathologically proven N2 or N3 disease
- •Any response to induction chemotherapy (whatever the regimen administered)
- •Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy
- •Lobectomy possible for the treatment of T disease
- •Availability for participating in the detailed follow-up of the protocol
- •Informed consent
排除标准
- •Prior treatment with radiotherapy or surgery
- •Karnofsky PS < 60
- •Functional or anatomical contra-indication to mediastinal radiotherapy
- •Functional or anatomical contra-indication to surgical lobectomy
- •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
- •Malignant pleural or pericardial effusion
- •Neutrophils < 2,000/mm³
- •Platelet cells < 100,000/mm3
- •Serum bilirubin > 1.5 mg/100 ml
- •Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- •Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- •Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
- •Uncontrolled infectious disease
- •Hearing loss
- •Symptomatic polyneuropathy
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule
结局指标
主要结局
Survival
时间窗: Survival will be dated from the day of registration until death or last follow up
次要结局
- Local control rate(After completion of treatment)
- Toxicity(After each course of chemotherapy and at the end of treatment)
- Operative mortality and morbidity(To be observed during the 30 days following the surgical procedure)
研究者
研究点 (22)
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